Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension

Not Applicable

Completed

• Conditions: Blood Pressure; Hypertension
• Interventions: Other: Pharmacist Drug Therapy Management

• Registration Number: NCT04098978
• Lead Sponsor: University of Louisiana Monroe

Brief Summary

This study will measure the effect of a novel pharmacy practice model on pediatric patients with hypertension. In North Louisiana, many patients have to travel to see subspecialists for treatment for hypertension and elevated blood pressure, which has many costs including direct medical costs, direct nonmedical costs, and indirect costs like missed time from work, school, or social obligations. Also, many patients who have to travel to get to their appointments have a high rate of missed appointments, which can be bad for overall health.

This study will use a pharmacist to perform collaborative drug therapy management with pediatric cardiologists to manage therapy for patients with hypertension or elevated blood pressure. Patients will monitor blood pressure at home and follow up with the pharmacist by telecommunications. Pharmacist drug therapy management and telemedicine have been studied separately, but this is the first study with pharmacist drug therapy management by telemedicine for pediatric patients. If this model is successful, it could be replicated in other rural areas to improve patient care and reduce healthcare costs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Study Start: 2020-01-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

Not provided

Exclusion Criteria

• Physical preclusion to taking blood pressure, such as lack of limbs or any congenital or acquired anatomical defect preventing routine measurement of blood pressure
• Participation in another treatment or intervention study for hypertension during the study period
• Inability to speak English
• For patients under 18 years old, not having at least one parent or guardian able to speak English
• Patients who are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacist Drug Therapy Management	Pharmacist Drug Therapy Management	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with adequately-controlled hypertension at 3 months.	3 months
Proportion of patients with adequately-controlled hypertension at 6 months.	6 months
Proportion of patients with adequately-controlled hypertension at 12 months.	12 months
Time to adequate control of hypertension.	Through study completion, an average of 1 year.	Defined as the first appointment with controlled hypertension.

Secondary Outcome Measures

Name	Time	Method
Costs to communities	Through study completion, an average of 1 year.	Includes healthcare resource utilization, lost productivity
Appointment adherence	Through study completion, an average of 1 year.	Proportion of appointments attended
Number and type of serious adverse drug events	Through study completion, an average of 1 year.	Number of serious adverse drug events in aggregate and subgrouped.
Number of unplanned health care encounters related to hypertension	Through study completion, an average of 1 year.	Surrogate for adverse event associated with treatment or disease state.
Costs to patients	Through study completion, an average of 1 year.	Includes direct medical, direct nonmedical, indirect costs
Cost to healthcare systems and payors	Through study completion, an average of 1 year.

Trial Locations

Locations (1)

Ochsner Health Center for Children; 🇺🇸 West Monroe, Louisiana, United States